Comparing of antenatal intramuscular adminestration of two doses of betamethasone every 12 hours with standard method every 24 hours on acute neonatal pulmonary complications in preterm infants born from women with preterm premature of membrane
Objective: To determine the effect of two doses of betamethasone injections every 12 hours with the standard method every 24 hours on acute pulmonary complications in preterm infants born to mothers with gestational age of 26 to 34 weeks with PROM . Study Design: Randomized - Single blind - control by standard method - single centre . Study population: Pregnant women with a singleton pregnancy at the age of 26 to 34 weeks and premature rupture of membranes . Inclusion criteria:" Healthy women pregnant with singleton pregnancies and premature rupture of membranes at gestational age 26 to 34 weeks without the need for an immediate termination of pregnancy" . Exclusion criteria:" Presence of any increased blood pressure; diabetes ; intrauterine growth retardation; chorioamnionitis; fetal anomaly; fetal distress ; steroid use by mother and any disease that corticosteroids use are contraindicated" . Sample size : 156 patient. In intervention group : Antenatal intramuscular adminestration of two doses of 12 mg betamethasone every 12 hours for women with preterm premature of membrane . Control group : Antenatal intramuscular adminestration of two doses of 12 mg betamethasone every 24 hours for women with preterm premature of membrane . Study time: 2 years . Study outcome: Acute neonatal respiratory complications and Apgar score ( first and fifth minute ) of babies born after the last dose injection of betamethasone .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120415634N2
Registration date:2017-09-27, 1396/07/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-27, 1396/07/05
Registrant information
Name
Tayebeh Jahed Bozorgan
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5506 6263
Email address
tayebe.jahed@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Preventive Gynecology Research Center of Imam Hossein Hospital
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of antenatal intramuscular adminestration of two doses of betamethasone every 12 hours with standard method every 24 hours on acute neonatal pulmonary complications in preterm infants born from women with preterm premature of membrane
Public title
The effect ofantenatal intramuscular adminestration of two doses of betamethasone every 12 hours on acute pulmonary complications in preterm infants born
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: " Healthy women pregnant with singleton pregnancies and premature rupture of membranes at gestational age 26 to 34 weeks without the need for an immediate termination of pregnancy" .
Exclusion criteria:" Presence of any increased blood pressure; diabetes ; chorioamnionitis ; intrauterine growth retardation; fetal anomaly; fetal distress ; steroid use by mother and any disease that corticosteroids use are contraindicated'.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
156
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomization by table of random number
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the Shahid Behesti University of the Medical Sciences ,Theran , Iran
Street address
" SIDE OF AYATOLLAH TALEGANI HOSPITAL , SHAHID ARABI AVENUE , YAMAN AVENUE ,SHAHID CHAMRAN HIGHWAY "
City
Tehran
Postal code
1985717443
Approval date
2014-09-28, 1393/07/06
Ethics committee reference number
SBMU.REC.1393.308
Health conditions studied
1
Description of health condition studied
Respiratory and cardiovascular disorders specific to the perinatal period
ICD-10 code
Respirator
ICD-10 code description
Hyaline membrane disease
Primary outcomes
1
Description
Occurrence of Respiratory distress of newborn
Timepoint
First seven days of the neonatal period
Method of measurement
questionnaire
Secondary outcomes
1
Description
APGAR
Timepoint
The first and fifth minutes after birth
Method of measurement
questionnaire
Intervention groups
1
Description
Caspian tamin,Pharmaceutical Co.Rhast-IRAN,Betamethasone 4mg/ml .( In control group : Antenatal intramuscular two doses of 12 mg betamethasone every 24 hours administer to women with preterm premature of membrane) .
Category
Treatment - Drugs
2
Description
Caspian tamin,Pharmaceutical Co.Rhast-IRAN,Betamethasone 4mg/ml . ( In intervention group : Antenatal intramuscular two doses of 12 mg betamethasone every 12 hours administer to women with preterm premature of membrane) .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdiyeh Hospital
Full name of responsible person
parisa hashemi
Street address
" Fadaian Eslam Highway; Shoush squre"
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Imam Hossein Hospital ; Preventive Gynecology Research Center
Full name of responsible person
Farah farzaneh
Street address
Madani street ; Imam Hossein Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Imam Hossein Hospital ; Preventive Gynecology Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mahdiyeh Hospital
Full name of responsible person
Parisa Hashemi
Position
Resident of Obstetric & Gynecology
Other areas of specialty/work
Street address
FADAIAN ISLAM HIGH WAY ,SHOOSH SQUARE
City
Tehran
Postal code
Phone
+98 21 5506 6263
Fax
Email
parisahashemi62@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
tayebeh Jahed Bozorgan
Position
Assistant Professor
Other areas of specialty/work
Street address
Mahdiyeh Hospital
City
Tehran
Postal code
Phone
+98 21 5506 6263
Fax
Email
tayebeh.jahed@yahoo.com;tayebe.jahed@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Madiyeh Hospital
Full name of responsible person
Parisa Hashemi
Position
Resident of Obstetric & Gynecology
Other areas of specialty/work
Street address
" FADAIAN ISLAM HIGH WAY , SHOOSH SQUARE "
City
Tehran
Postal code
Phone
+98 21 5506 6263
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)